Pregabalin
- Product NDC
- 70518-3346
- 11-digit product format
- 705183346
- Labeler code
- 70518
- Product ID
- 70518-3346_3e9d0ed6-d962-341c-e063-6394a90a4193
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- Pregabalin
- Dosage form
- CAPSULE
- Route
- ORAL
- Labeler
- REMEDYREPACK INC.
- Application
- ANDA209357
- Marketing category
- ANDA
- Marketing start
- 2022-01-27
- Substance
- PREGABALIN
- Active strength
- 300 mg/1
- DEA schedule
- CV
- NDC exclude flag
- No
- Listing certified through
- 2027-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- Pregabalin
- Listing expiration
- 2027-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| PREGABALIN | 300 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | 55JG375S6M |
| Rxcui | 483444 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 70518-3346-0 | Pregabalin | 60 in 1 BOTTLE, PLASTIC | CAPSULE | 60 | | 7 |
| 70518-3346-1 | Pregabalin | 30 in 1 BLISTER PACK | CAPSULE | 30 | | 7 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 70518-3346 | PREGABALIN CAPSULE [REMEDYREPACK INC.] | 5 | Current NDC, Legacy NDC, 2 package rows | 20241004_326c643a-23c5-4dab-9266-abc22ca1f874.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Marketing end | Sample | Exclude flag | Status |
|---|
| 70518-3346-0 | 70518334600 | 60 CAPSULE in 1 BOTTLE, PLASTIC (70518-3346-0) | 60 capsule | 2022-01-27 | 0000-00-00 | No | No | Current |
| 70518-3346-1 | 70518334601 | 30 CAPSULE in 1 BLISTER PACK (70518-3346-1) | 30 capsule | 2023-03-10 | | No | No | Historical |